EndoClot

GUDID 26972011720223

EndoClot Plus Co.,Ltd.

Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel

• Primary Device ID: 26972011720223
• NIH Device Record Key: 5f5b1f06-af5a-4cd5-a147-f94a52594691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoClot
• Version Model Number: SIS-15
• Company DUNS: 544357082
• Company Name: EndoClot Plus Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -3 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	16972011720226 [Primary]
GS1	26972011720223 [Package]; Contains: 16972011720226; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• PLL: Submucosal Injection Agent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-01
• Device Publish Date: 2021-06-23

On-Brand Devices [EndoClot ]

• 26972011720216: EndoClot Submucosal Injection System EndoClot® Submucosal Injection Agent is intended for use i
• 26972011720223: SIS-15
• 26972011720018: EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS
• 26972011720513: EndoClot® Air Compressor Connecting Tube